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Shisi Pharmaceutical Group (02005) has obtained pharmaceutical production registration approvals for four products, including potassium chloride injection (II) (100ml: 1.5g) and sodium hyaluronate eye drops 0.3% (0.4ml: 1.2mg)

Zhitongcaijing·08/06/2026 08:41:14
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Zhitong Finance App News, Shisi Pharmaceutical Group (02005) announced that the group has obtained drug production registration approval from the China National Drug Administration for the following four products, all of which are deemed to have passed the consistency evaluation.

one. Potassium chloride injection (II) (100ml: 1.5g): This product of the Group is the second domestic company to be approved. It is a Class 3 chemical and is mainly used to treat hypokalemia when oral potassium supplementation is not possible. This product further enriches the Group's therapeutic infusion product matrix and strengthens the Group's product layout and specialty clinical supply capacity in the ICU field.

II. Sodium hyaluronate eye drops 0.3% (0.4ml: 1.2mg): This product belongs to class 4 chemicals and is mainly used to treat corneal epithelial damage associated with the following diseases: endogenous diseases such as Sjörg syndrome, Sjörg syndrome, and dry eye syndrome; and exogenous diseases such as post-operative, medicinal, trauma, and contact lens wearing.

III. Sodium Hyaluronate Eye Drops 0.1% (0.4ml: 0.4mg): This product belongs to Class 4 chemicals and is mainly used for dry eyes to relieve dry eye symptoms.

Both sodium hyaluronate eye drops are packaged in a single dose without preservatives. Together with polyvinyl alcohol eye drops approved earlier, a product portfolio covering dry eye of varying severity has been created to provide patients with stratified treatment options.

The group strategically lays out the ophthalmic medicine sector with a single-dose, preservative-free dosage form. It has built a product matrix including anti-infection, anti-allergy, eye pressure reduction, artificial tears, and eye anti-inflammatory, forming a dual-channel layout for in-hospital prescription drugs and retail OTC.

IV. Metoclopramide tablets (5mg): This product is a chemical class 3. It is mainly used for symptomatic treatment of symptoms of nausea and vomiting caused by various causes, short-term treatment of symptomatic gastroesophageal reflux where conventional treatment is ineffective, and relief of symptoms of acute and recurrent diabetic gastroparesis. As stated in the company's announcement dated February 27, 2026, the Group's metoclopramide source drug has been approved by the State Drug Administration and registered as an active ingredient for use in marketed formulations.